Bracco's VueJect Receives FDA 510(k) Clearance and Health Canada Authorization as First Dedicated Ultrasound Contrast Delivery System for Cardiology Imaging
核心洞察
Bracco Imaging (搜索)'s VueJect (搜索)®, the first dedicated ultrasound contrast delivery system for cardiology, has received FDA 510(k) clearance and Health Canada authorization.
VueJect (搜索) is designed to improve workflow efficiency, reduce operator variability, and enable continuous administration of ultrasound contrast agents during cardiac imaging.
The regulatory milestones mark the first step in Bracco's global commercialization strategy, with initial availability in the U.S. and Canada and additional submissions planned.
Bracco Imaging (搜索) announced on August 11, 2026, that VueJect (搜索)® has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and authorization from Health Canada, marking a significant global milestone as the first dedicated ultrasound contrast delivery system engineered specifically to support cardiology imaging.
The dual regulatory achievements represent the initial phase of Bracco's broader global commercialization strategy for VueJect (搜索), with the device set to become available first in the United States and Canada. The company has indicated that additional regulatory submissions are planned in other markets.
Advancing the CEUS Ecosystem
VueJect (搜索) expands Bracco's growing contrast-enhanced ultrasound (CEUS) ecosystem by providing a dedicated contrast delivery solution designed to improve workflow efficiency through a streamlined contrast administration process, reduce operator variability leading to consistency during contrast administration, and enable continuous administration of ultrasound contrast agents to support more consistent enhancement during cardiac imaging procedures.
"VueJect (搜索) represents a significant strategic milestone for Bracco as we continue investing in innovations that advance contrast-enhanced ultrasound worldwide," said Fulvio Renoldi Bracco, Vice Chairman and CEO, Bracco Imaging (搜索). "Beginning with regulatory approvals in the United States and Canada, VueJect further advances our integrated ultrasound portfolio and reflects our commitment to expanding access to innovative diagnostic solutions around the world."
Setting a New Standard in Contrast Administration
The system is designed to administer Lumason/SonoVue (搜索) in dilution during echocardiography procedures, adding a dedicated injector to Bracco's Ultrasound-Enhancing Agent portfolio. Luca Frazzoli, Global Head of Ultrasound at Bracco Imaging (搜索), described VueJect (搜索) as "a defining addition to our CEUS ecosystem," adding that "as we bring this technology to more markets, we expect it to change what sonographers and physicians come to expect from contrast administration, setting a new standard for consistency and confidence in everyday practice."
Robert Mitchell, MBA, Director of the Ultrasound Platform for the Americas, emphasized the clinical significance: "VueJect (搜索) provides cardiac sonographers with a more standardized approach to contrast administration, helping deliver more consistent CEUS examinations, day in and day out."
Commercial Outlook
Following these regulatory milestones, Bracco is preparing for commercial launch while advancing plans for future regulatory submissions in additional global markets. VueJect (搜索) has received 510(k) clearance from the U.S. FDA and is licensed by Health Canada under Medical Device License No. 115637.
Bracco Group, founded in 1927, is a global leader in diagnostic imaging with operations across more than 100 countries, a workforce of over 4,000 employees, and consolidated annual revenues of approximately €2 billion, 88% of which is generated by international markets. The company invests around 9% of its reference turnover in Research & Development.